The Effect of Lactoferrin on Pain Management Following Cesarean Section (NCT07502235) | Clinical Trial Compass
Not Yet RecruitingPhase 3
The Effect of Lactoferrin on Pain Management Following Cesarean Section
Egypt90 participantsStarted 2026-03-26
Plain-language summary
This study evaluates whether lactoferrin, a naturally occurring protein with anti-inflammatory and antioxidant properties, can improve pain control after cesarean section. Effective management of postoperative pain is essential to support maternal recovery, mobility, and the ability to care for the newborn, while minimizing reliance on opioid medications and their associated side effects.
In this randomized, double-blind, placebo-controlled trial, women undergoing elective cesarean section will receive either oral lactoferrin or a matching placebo in addition to standard postoperative analgesia. Lactoferrin will be administered starting before surgery and continued for 48 hours after delivery.
The study will assess whether lactoferrin reduces postoperative pain intensity and opioid consumption, and improves recovery outcomes such as time to mobilization, patient satisfaction, and incidence of common postoperative symptoms. Safety and tolerability will also be evaluated.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Referred to elective (non-emergency) cesarean section
* Undergoing spinal anesthesia) with American Society of Anesthesiologists (ASA) classification I and II
* Term gestational age
Exclusion Criteria:
* History of seizures
* Pre-eclampsia or eclampsia
* Hypertension
* Use of narcotic painkillers for 24 h before the intervention
* Medications inducing neuropathy including Amiodarone, Metronidazole, Phenytoin \& Colchicine.
* Prolongation of cesarean section (more than 1.5 h)
* Increase in the size of the incision
* Occurrence of any unusual complication during surgery,
* Failure of spinal anesthesia and its conversion to general anesthesia
* Contraindications to spinal anesthesia
* Use of interacting medication: fluoroquinolones, loratadine, fexofenadine, alvimopan, armodafinil
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.